[Federal Register Volume 66, Number 143 (Wednesday, July 25, 2001)]
[Proposed Rules]
[Pages 38591-38594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 00P-1322]


Food Safety and Food Labeling; Presence and Labeling of Allergens 
in Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on the labeling of food products containing allergens. The 
purpose of the meeting is to stimulate discussion and to obtain 
information to help FDA determine what additional actions may be 
necessary to provide consumers with adequate information on product 
labels. The meeting will focus on: Source or plain English labeling; 
advisory labeling (e.g., ``May contain [name of food allergen]''); and 
labeling of ingredients exempted from declaration (common or usual 
names of flavorings, spices, and colors; incidental additives).

DATES: The public meeting will be held on August 13, 2001, from 9 a.m. 
to 4 p.m. Please preregister by close of business on August 6, 2001. 
Preregistered persons should check in before the meeting between 8:30 
a.m. and 9 a.m. Late registration will be accepted contingent on space 
availability. Comments must be submitted no later than October 29, 
2001.

ADDRESSES: The meeting will be held at the Cohen Bldg., 330 
Independence Ave. SW., Washington, DC 20201, 202-619-1299 (Metro: 
Federal Center SW.). All attendees must enter the building at the 
Independence Ave. entrance.
    Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. You may also send comments to the Dockets Management Branch 
at the following e-mail address: [email protected], or at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT:
    For registration: Please register by close of business on August 6, 
2001, electronically at http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Once on this Internet site, select 
Docket No. 00P-1322 (Food Labeling and Allergen Contamination Control) 
and follow the directions. You may also register by mail at Dockets 
Management Branch (address above).
    For registration information: Ayesha Weaver, Center for Food Safety 
and Applied Nutrition (HFS-822), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-3587, FAX 202-205-5295.
    For general information: Catalina Ferre-Hockensmith, Center for 
Food Safety and Applied Nutrition (HFS-822), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168, FAX 
202-205-5295.

SUPPLEMENTARY INFORMATION:

I. Background

    Each year FDA receives reports of consumers who experience adverse 
reactions following exposure to allergenic substances in foods. Food 
allergies are abnormal responses of the immune system, especially the 
production of allergen-specific IgE antibodies, to naturally occurring 
proteins in certain foods that most individuals can eat safely. Most 
consumers are aware of their specific sensitivities and rely on the 
food label to avoid foods that might result in an allergenic reaction. 
However, adverse reactions often occur when an allergen-sensitive 
consumer consumes an allergenic substance that has not been declared on 
the food label.
    Section 403 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 343) requires food labels to bear a complete listing of all 
the ingredients in a food. This permits consumers to obtain accurate 
information about the foods that they eat by reading the ingredient 
list. However, the act and FDA's regulations provide two narrow 
exemptions from the ingredient labeling requirement. First, section 
403(i) of the act provides that flavorings, spices, and colors may be 
declared collectively without naming each one. In some instances, these 
collective ingredients contain subingredients that are allergens. (FDA 
is exploring whether allergenic ingredients in spices, flavorings, or 
colors should be declared, section 403(i) of the act notwithstanding.) 
Second, FDA regulations exempt incidental additives (e.g., processing 
aids) from ingredient declaration if they are present in a food at 
insignificant levels and do not have a technical or functional effect 
in the finished product (Sec. 101.100(a)(3) (21 CFR 101.100(a)(3))). 
Thus, in some cases

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food labels may not provide consumers with food allergies with 
information about all the ingredients that are in the foods that they 
eat.
    In addition to exemptions for ingredient labeling, there are other 
ways in which consumers may inadvertently come in contact with 
allergenic substances. For instance, some consumers may be unaware of 
the allergenic source of ingredients declared by their common or usual 
names in the ingredient statement. For example, consumers may not 
understand that the source of the ingredients ``whey'' and ``casein'' 
is ``milk,'' which is a common food allergen. Another area of concern 
is the potential, inadvertent introduction of an allergenic ingredient 
to a food (e.g., cross-contact during manufacturing where traces of 
peanuts end up in a product that does not normally contain peanuts 
because the product is manufactured on the same production line as a 
product containing peanuts).
    The undeclared presence of allergens in foods is a serious public 
health issue because the ingestion of food allergens is potentially 
life-threatening to sensitive individuals. Therefore, as part of its 
public health mission to keep food safe, FDA has been focusing 
increased attention and activity on issues relating to food allergens, 
especially the proper labeling of products containing such allergens 
and the control of food allergens in products not intended to contain 
such allergens.
    Currently, the only successful method to manage food allergy is 
avoidance of foods containing the allergen. FDA's allergen awareness 
efforts are currently focused on the eight foods that are most 
frequently implicated in serious allergic responses: (1) Peanuts; (2) 
soybeans; (3) milk; (4) eggs; (5) fish; (6) crustacea (e.g., lobster, 
crab, shrimp); (7) tree nuts (e.g., almonds, chestnuts, macadamia nuts, 
pecans, walnuts, hazelnuts or filberts, cashews, brazil nuts, 
pistachios, pine nuts); and (8) wheat.
    There has been growing activity surrounding food allergens. The 
number of allergen-related food recalls increased steadily since 1990. 
Further, FDA has received correspondence from consumers, as well as 
from members of Congress (on behalf of their constituents) expressing 
concern about undeclared allergens in foods. FDA has also received a 
citizen petition requesting agency action to address food allergens 
(Docket No. 99P-2148). Similarly, in May of 2000, the attorneys general 
of nine States expressed their concern about food allergens and 
submitted a petition asking FDA to amend its regulations on food 
labeling and manufacturing practices (Docket No. 00P-1322).
    In response to food allergy concerns, the Food Allergy Issues 
Alliance (a private group comprised of industry and trade group 
representatives and a consumer group, as well as a scientific advisor 
representing academia) recently submitted (May 2001) a consensus 
document on guidelines for food allergen labeling (Ref. 1). The Food 
Allergy Issues Alliance asserted that the guidelines would address food 
allergen issues their member companies would be implementing soon 
without requiring FDA to amend or issue regulations.
    FDA replied to their submission (Refs. 2, 3, and 4) stating that 
the agency considered the guidelines a significant step forward in 
addressing the prevalence and identification of the eight most common 
food allergens in plain, simple language. The agency also indicated it 
was pleased that the document recognized the public health need to 
disclose food allergens. FDA finally noted that the Food Allergy Issues 
Alliance guidelines laid the groundwork for addressing additional food 
allergen issues in the future. The agency finds the guidelines 
consistent with both our positions on food allergens (as articulated in 
the past) and with the purpose behind the public meeting, as described 
later in this document, and therefore is an appropriate starting point 
for discussions at the public meeting.
    FDA's concern about food allergens has prompted several agency 
actions, most notably a notice to manufacturers on the label 
declaration of allergens (1996), an FDA/State partnership to increase 
industry's understanding of allergens and to identify effective 
manufacturing controls (1998), and issuance of food allergen guidance 
documents (2001). Information on these initiatives is available at the 
FDA Web site on allergens at http://www.cfsan.fda.gov/dms/wh-
alrgy.html.

II. Public Meeting--August 13, 2001

    FDA is announcing a public meeting on August 13, 2001, to explore 
certain allergen-related labeling issues in greater detail. The meeting 
is intended to aid the agency in determining what additional actions 
may be warranted to further assist consumers with food allergies in 
identifying products containing food allergens and to assist 
manufacturers in producing foods that are safe for consumers with food 
allergies.
    The agency is requesting written and oral comments in three topic 
areas relating to food allergens within the context outlined above: (1) 
Source or plain English labeling; (2) advisory labeling (e.g., ``May 
contain [name of food allergen]''); and (3) labeling of ingredients 
exempted from declaration (common or usual names of flavorings, spices, 
and colors; incidental additives). Recommendations from the petition 
submitted by the attorneys general of nine States (Docket No. 00P-1322) 
and the allergen-labeling guidelines from the Food Allergy Issues 
Alliance (Ref. 1) are incorporated into the discussion of the three 
topic areas, as appropriate.

A. Source or Plain English Labeling

    FDA recognizes that many of the common or usual names for 
ingredients listed in the ingredient statement are not understood by 
consumers to be derived from food allergens (e.g., ``caseinate'' or 
``whey'' derived from ``milk'' and ``albumin'' derived from ``egg''). 
FDA is considering whether additional labeling of food products is 
necessary in some instances to ensure that allergenic consumers are 
informed about the presence of food allergens.
    FDA is considering how best to make source or plain English 
labeling more widely available to consumers so that the labels will be 
more understandable. To assist the agency in its deliberations, FDA is 
asking several questions relating to source labeling:
    1. What plain English terms would be understandable for the eight 
most common food allergens?
    2. What source or plain English labeling format or formats would be 
most informative to consumers? Are the formats from the Food Allergy 
Issues Alliance appropriate and sufficient? Are the recommendations in 
the petition from the attorneys general of nine States warranted and 
beneficial? Are multiple formats confusing to consumers, and if so, is 
there a single format that would be preferable? If so, why?
    3. Should source or plain English labeling be voluntary or 
mandatory for the eight most common food allergens?

B. Advisory Labeling (e.g., ``May contain [name of food allergen]'')

    Advisory labeling includes statements such as ``may contain 
peanuts'' or ``made on shared equipment'' on food packaging labels. 
FDA's current position is that advisory labeling should not be used in 
lieu of adherence to good manufacturing practices (GMPs) because 
adhering to GMPs is essential for effective reduction of adverse 
reactions. Food that contains an allergen due to cross-contact or other 
contamination may be considered adulterated under section 402(a)(4) of 
the act (21 U.S.C. 342(a)(4)) because it has been prepared, packed, or 
held under insanitary

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conditions that may render the food injurious to health. Thus, FDA 
believes advisory labeling should not be the norm, and manufacturers 
should strive to eliminate the presence of allergenic materials that 
are not intentionally added to a specific food product.
    However, FDA recognizes that advisory labeling is an attempt by 
manufacturers to inform consumers of the possibility that cross-contact 
may have occurred such that the product contains an allergenic 
substance. FDA is considering whether, and if so, under what 
circumstances advisory labeling should be permitted when appropriate 
manufacturing controls are not sufficient to guarantee the absence of 
allergenic substances in a particular food product. If permitted, clear 
criteria will be needed to guide the use of such statements. 
Additionally, FDA is assessing whether advisory labeling is useful to 
consumers, how consumers interpret advisory labeling statements, and 
what wording would be most understandable. To help the agency better 
understand if there is a need for advisory labeling, when it would be 
appropriate, how such statements would be used by consumers, and what 
wording would be most helpful to the consumer, the agency asks the 
following questions:
    1. Under what circumstances, if any, should advisory labeling 
statements (e.g., ``May contain [name of allergen]'') be permitted, and 
what impact would those circumstances have on manufacturers and on 
consumers? Should the recommendations in the petition from the 
attorneys general of nine States be adopted? Do the criteria from the 
Food Allergy Issues Alliance form a reasonable basis for determining 
when a manufacturer may use advisory labeling on a particular product 
or should other criteria be used? Why?
    2. Are there better alternatives for advisory labeling than the 
type of wording that currently exists (e.g., ``May contain [name of 
specific allergen],'' ``Made on shared equipment,'' ``Manufactured in a 
facility that also processes [name of specific allergen]'')? Do such 
statements adequately inform consumers of possible cross-contact with 
allergenic materials? How do consumers interpret the wording of such 
labeling? Should advisory labeling statements be prescriptive (i.e., 
one or more specific statements) or flexible?
    3. Where should advisory labeling statements be located on the food 
label? How prominent should advisory labeling statements be on the 
label? Should the location and prominence of advisory labeling 
statements be prescribed?

C. Labeling of Ingredients Exempted From Declaration (Common or Usual 
Names of Flavorings, Spices, and Colors; Incidental Additives)

1. Common or Usual Names of Flavorings, Spices, and Colors
    As previously noted, the collective naming of flavors, spices, and 
certain colors is one of the exemptions to the requirement for the 
complete labeling of ingredients (section 403(i) of the act). This 
exemption permits these ingredients to be listed collectively in the 
ingredient statement (e.g., ``Ingredients: * * *flavorings * * *'') 
without naming each by its common or usual name. Food labels with 
collectively named flavorings, spices, and colors may not adequately 
inform individuals who wish to avoid allergenic substances, 
particularly when the allergenic substance is not specifically 
identified.
    FDA believes that the declaration of allergenic ingredients in 
individual flavorings, spices, and colors is necessary for consumers to 
adequately protect themselves from exposure to food allergens. On a 
case-by-case basis, FDA has used notice-and-comment rulemaking to 
require the declaration of individual allergenic flavorings, spices, 
and colors. This is a labor-intensive and time-consuming process for 
the agency.
    FDA is considering whether continuing to address allergenic 
flavorings, spices, and colors on a case-by-case basis is the best 
approach available to the agency. The petition from the attorneys 
general of nine States (Docket No. 00P-1322) recommended amending the 
regulations for flavorings derived from one of the eight most common 
allergenic substances to require the declaration of the presence of the 
allergen (e.g., peanut flavoring). The allergen-labeling guidelines 
from the Food Allergy Issues Alliance (Ref. 1) advocated additional 
voluntary disclosure of food allergens that are intentionally part of 
foods, including substances exempted from labeling by regulations 
(e.g., flavorings). Questions for the public meeting relate to the 
alternatives available to the agency:
    1. Should the agency continue to address the labeling of individual 
allergenic flavorings, spices, and colors on a case-by-case basis, or 
should there be a generally applicable policy?
    2. Should the information on allergenic components of flavorings, 
spices, and colors be included in the ingredient list? Is there a 
better location or format for this information? Explain.
    3. For individual flavorings, spices, or colors that contain one of 
the eight most common allergens, should listing the common or usual 
name of the individual flavoring, spice, or color on the product 
labeling be voluntary or mandatory?
2. Labeling of Incidental Additives
    Incidental additives that are present in a food at insignificant 
levels and do not have any technical or functional effect in that food 
have been exempted by regulation from labeling on an ingredient 
statement (Sec. 101.100(a)(3)). Incidental additives include substances 
that have no technical or functional effect in the finished product, 
processing aids, and substances that may migrate to the food from 
equipment or packaging. FDA has stated that because very small amounts 
of some allergenic substances can cause serious allergic responses, 
allergens that cause serious allergic reactions cannot be considered to 
be present at an ``insignificant'' level in the food. The agency has 
stated that all allergenic substances introduced as ingredients or as 
the result of manufacturing processes do not qualify as incidental 
additives and must be declared in the ingredient statement on the label 
of a food product (Ref. 5).
    With regard to incidental additives, FDA understands that the main 
difficulty is that manufacturers may be unaware that a particular minor 
ingredient or processing byproduct may be allergenic and therefore must 
be declared on product labels. The petition from the attorneys general 
of nine States (Docket No. 00P-1322) recommended amending the 
regulations for ingredients that are derived from one of the eight most 
common allergenic substances to specify that such ingredients may not 
be considered incidental additives under Sec. 101.100(a)(3) and must be 
declared on the product label. The allergen-labeling guidelines from 
the Food Allergy Issues Alliance (Ref. 1) suggested that food companies 
follow FDA's current guidance regarding the labeling of ``incidental 
ingredients'' that are or that contain one of the eight most common 
food allergens by declaring the allergen in the ingredient list of the 
food. The questions for the public meeting relate to gathering 
information and exploring educational alternatives to increase 
manufacturer understanding:
    1. What, if any, minor ingredients would manufacturers be unlikely 
to recognize as containing food allergens and therefore not include on 
the label, and what kinds of manufacturing processes would 
manufacturers be unlikely to recognize as inadvertently introducing 
food allergens?
    2. When products that contain food allergens will be further 
processed or

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repacked, is food allergen labeling sufficient on such intermediate 
products or is it necessary to have clearer labeling on intermediate 
products to ensure that food allergens are appropriately declared on 
the retail packaging of the final product?
    3. Should the agency codify its policy to specifically state that 
incidental additives that are food allergens are not exempt from 
labeling and must be declared in the ingredient statement on the label?

III. Summary

    FDA's public meeting, scheduled for August 13, 2001, is intended to 
help the agency determine what additional actions may be warranted to 
provide consumers with adequate food allergen information on product 
labels. FDA recognizes that there are additional food allergen areas 
that may need to be addressed at future meetings or through agency 
actions, e.g., food handling practices and providing food allergen 
information in restaurant settings. However, at this time, the agency 
is focusing on issues relating to labeling and manufacturing of the 
eight most common food allergens; therefore, the public meeting will be 
restricted to discussion of the topic areas described above.

IV. Registration and Requests to Make Oral Presentations

    If you would like to attend the meeting, you must preregister in 
writing by close of business on August 6, 2001, either electronically 
or by mail (information above). You must provide your name, title, 
business affiliation (if applicable), address, telephone number, fax 
number, e-mail address, and the type of organization you represent 
(e.g., industry, consumer organization).
    Preregistered persons should check in before the meeting between 
8:30 a.m. and 9 a.m. Persons who have not preregistered may register 
before the meeting between 8:30 a.m. and 9 a.m., dependent on space 
availability. All attendees must enter the building at the Independence 
Ave. entrance. If you need special accommodations due to disability 
(e.g., sign language interpreter), please inform the contact person 
when you register.
    If, in addition to attending, you wish to make an oral presentation 
during the meeting, you must indicate this on your registration form 
and submit: (1) A brief written statement of the general nature of the 
views you wish to present, and (2) the names and addresses of all 
persons who will participate in the presentation. Depending on the 
number of people who register to make presentations, we will limit the 
time allotted for each presentation (from 3 to 5 minutes). If you 
decide at the meeting that you wish to make a comment, you must sign up 
at the registration desk, dependent on time availability. It is 
anticipated that, if time permits, persons attending the meeting will 
have the opportunity to ask questions during the meeting.

V. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding the topics 
addressed at the public meeting on or before October 29, 2001. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

VI. Transcripts

    You may access a copy of the transcript on the FDA Web site at 
http://www.fda.gov, request a transcript of the meeting from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 20 
working days after the meeting, at a cost of 10 cents per page, or 
examine a transcript of the meeting after September 10, 2001, at the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

VII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen between 9 a.m. and 4 
p.m., Monday through Friday.
    1. Letter from Regina Hildwine, National Food Processors 
Association (NFPA), Lisa D. Katic, Grocery Manufacturers of America 
(GMA), and Anne Munoz-Furlong, Food Allergy and Anaphylaxis Network 
(FAAN), to Joseph A. Levitt, Center for Food Safety and Applied 
Nutrition (CFSAN), FDA, May 22, 2001.
    2. Letter from Joseph Levitt, CFSAN/FDA, to Regina Hildwine of 
NFPA, May 30, 2001.
    3. Letter from Joseph Levitt, CFSAN/FDA, to Lisa D. Katic of 
GMA, May 30, 2001.
    4. Letter from Joseph Levitt, CFSAN/FDA, to Anne Munoz-Furlong 
of FAAN, May 30, 2001.
    5. ``Compliance Policy Guide (CPG)--Statement of Policy for 
Labeling and Preventing Cross-Contact of Common Food Allergens'' 
http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm

VIII. Registration

    REGISTRATION FORM--PUBLIC MEETING ON ALLERGENS IN FOODS
Instructions: Please register using this form by close of business on 
August 6, 2001, electronically at http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Once on this Internet 
site, select Docket No. 00P-1322 (Food Labeling and Allergen 
Contamination Control) and follow the directions. You may also register 
by mail at Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 70852.
Name: ________________________
Title: ________________________
Organization: ________________________
Address: ________________________
Telephone: ________________________
FAX: ________________________
E-mail: ________________________
Please indicate the type of organization you represent:
Industry ________________
Government ________________
Consumer Organization ________________
Media ________________
Law Firm ________________
Educational Organization ________________
Other (specify) ________________
Do you wish to make an oral presentation?
Yes ______
No ______
If yes, you must also submit the following:
    1. A brief written statement of the general nature of the views you 
wish to present.
    2. The names and addresses of all persons who will participate in 
the presentation.
 Depending on the number of people who register to make presentations, 
we will limit the time allotted for each presentation (from 3 to 5 
minutes).

    Dated: July 20, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-18617 Filed 7-23-01; 12:16 pm]
BILLING CODE 4160-01-S